Note: Descriptions are shown in the official language in which they were submitted.
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PHARMACEUTICAL PRODUCT CONTAINER WITH TWO SEPARATE
SUBSTANCES AND A MIXING DEVICE AND DOSED DISPENSATION
Object of the Invention
The present invention is directed toward a
pharmaceutical product container having two separate
substances, a mixing device and a dosage dispenser. The
present invention permits the ~;x;ng of the two different
products, one of which is located inside the bottom
container itself, while the other one is located inside a
top container which has a weakened frangible member. A
tubular sleeve that terminates at the top in a discoidal
wing from which it continues in a truncated-cone shaped
portion for use as a medicine dropper. The tubular sleeve's
bottom terminates in a bevel edge. Upon screwing down a
cap, after a tamper evident seal has been removed, the bevel
edge of the tubular sleeve is pressed downward to allow
partial cutting of the weakened perimeter of the bottom of
the top container. This partial cut causes a total opening
between both compartments, but prevents the torn bottom from
being completely severed from the top container. Thus, the
present invention prevents the bottom from moving freely
around the inside of the bottom of the container once it has
been torn.
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Another object of the invention includes providing a
retaining device for preventing the removal of the sleeve
from the top container, once the bottom thereof has been
broken. For the same purpose, a seal between the bottom
container and the top container is included in the present
invention.
The present invention also utilizes a group of rings
and seals that maintain the sealing and-invulnerability of
the container, both before removal of the seal, maintaining
these two features in the components separate, as well as
after having broken the seal and having carried out the
mixing of the two components, maintaining the final sealing
and invulnerability of the inside of the container. Only
the discharge of the mixture through the dosing medicine
dropper is permitted.
The container according to the present invention
permits a final filling and conditioning that is very
diverse, permitting for varying the order of filling of the
top part and the bottom part, which prevents crossed
contamination, which is a typical problem in the
pharmaceutical industry.
BACKGROUND OF THE INVENTION
On the pharmaceutical market in general and especially
in the dermic, ophthalmic, oral and nasal sectors, there are
multiple products, such as certain eye drops, whose shelf
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life, once all of the ingredients have been mixed, in most
cases does not exceed four weeks.
In view of these circumstances, for some time now the
ingredients of the product are grouped in two parts that are
packaged separately and independently.
Generally, one of the parts is in a powdered
lyophilized form, while the other ones is in a liquid state.
Each one of the parts maintains individually its stability
during the proposed period of validity. The end user
himself is the one who must mix both parts when the product
is to be administered. The stability of the reconstituted
product suffices to guarantee the indicated time of use.
European Patent No. 344,849 and European Patent No.
217,425 provide attempted solutions to this problem.
European Patent No. 217,425 is directed towards a
device of this type, in which the mouth of the container has
a thread upon which the cap, which is provided with a seal,
is retained. Likewise, a cup is pressed on the mouth,
inside of which the tubular sleeve is housed. The tubular
sleeve terminates at its top edge with a discoidal wing and
continues in a truncated-cone shaped portion to carry out
the functions of a medicine dropper.
In this patent, after removing the seal from the cap,
the cap can be screwed down. The movement of the cap pushes
the tubular sleeve, which presses against the bottom of the
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cup, carrying out the breaking thereof and producing the
mixing of both products.
This patent presents the problem that after removing
the seal to effect the breaking of the bottom it is
necessary to exert a certain effort; at the same time to
permit the application of the mixed product it is necessary
to press the container. During this pressing step, the
discharge of the cup and/or of the tubular sleeve frequently
occurs. Thus, all of the product is inadvertently
dispensed. This is a serious problem because the correct
amount of the product has not been dispensed. This patent
also fails to disclose the use of seals, which prevents the
use of this patent for ~;x;ng of two liquids. This patent
also fails to accommodate for the in wlnerability of the
container, nor for a mechanism that permits the dose to be
repeated ~for example, a drop), nor is the versatility of
filling and final conditioning of the container set forth.
Concerning European Patent No. 344,849, this patent is
directed to a device, in which the cup has an outside
coaxial flap that includes an annular rib protruding
radially inwardly. The rib retains the cup on the edge of
the mouth of the container in such a way that it prevents,
when application takes place, the cup from being removed.
This feature however, is not necessary in this model given
that it does not act as a medicine dropper, because the
application of the mixed product is done entirely during
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treatment. In this patent, the breaking of the bottom is
done by pressing the cap and not screwing it, as in the
prior patent. Breaking the bottom by pressing creates
greater difficulty for breaking the bottom of the cup given
that the force to be exerted is much greater. Further, in
this patent, the cylindric sleeve may be removed by
effecting the application.
SUMMARY OF THE INVENTION
In order to solve the above cited problems in the prior
art, the present invention comprises a bottom container
consisting of a bottle upon which another top container is
placed. After breaking the bottom of the top container, the
tubular sleeve re~; ns retained in the top container, which
in turn is retained in the edge of the mouth of the bottom
container. The tubular sleeve and top container are
retained in such a way as to prevent, upon applying the
mixed product, removal of either the top container or the
tubular sleeve, or of both at the same time. The present
invention permits the application of the exact dosed amount
of the mixed product desired. The invention has diverse
projecting rings, labyrinth-type seals and embossments that
ensure a good sealing of the entire device, before and after
the breaking of the seal. Likewise, mishandling of the
container is prevented by providing seals to maintain
invulnerability of the same. Another advantage of the
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present invention exists in the versatility involved in the
filling stage, making it possible to carry out this stage in
two separate containers, and in the desired order.
In order to establish these advantages, the top
container of the invention is comprised of a coaxial
ret~; n; ng rib that is retained in the edge of the mouth of
the bottom container. The top container is also provided
with a helical thread to provide the threading of the cap
with a perimeter edge to establish the retention of the seal
of the cap and of an annular recess in the mouth thereof.
On the inside of the top container, which is made
conventionally, a tubular sleeve extends whose top
terminates in a discoidal wing. From the wing the top
container continues in a truncated-cone shaped portion,
which can function as a medicine dropper (depending on
whether or not it is of interest in the application). The
discoidal wing, in one of the embodiments, advantageously
has a certain conicity, to define a bevel that is
complemented with an annular recess provided in the mouth of
the top container, establishing the retaining of the tubular
sleeve in the mouth.
Conventionally, the bottom edge of the tubular sleeve
is bevel-edged. This bevel edge has been improved in the
following embodiment, so that the bottom edge is horizontal
and has a longitudinal, continued decreasing cross sectioned
appendix or projection which facilitates partial breaking of
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the bottom of the top container, without requiring any
additional effort. The breaking is only partial because
there is a longit-l~;n~l recess in the side diametrically
opposite the tearing appendix. This recess, which prevents
the total breaking of the bottom of the top container,
permits the bottom to remain joined to the top container by
a fine segment. The torn bottom does not hamper the ~;x;ng,
because it is flexible, but it does prevent the bottom of
the top container from falling inside the bottom container.
The bottom of the top container, which is also made
conventionally, can have a perimeter weakening in the inside
wall. The weakening can be included in the outside wall, or
in both, for the purpose of providing better breaking and
preventing formation of particles due to a poor cutting from
appearing. The perimeter weakening also ensures the sealing
of the top container, against migration which may exist
through the bottom wall of the top container, giving a
greater thickness to the center area of the bottom; given
that the migration depends on the surface in contact and on
the thickness of the same.
Therefore, by use of the present invention and after
removal of the seal from the cap, the same can be screwed
down effecting the displacement of the tubular sleeve, which
partially breaks the bottom of the top container without
exerting additional effort and establishes a mutual axial
retaining between the cup and the tubular sleeve. Upon
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effecting the ret~;ning on the peripheral edge of the
discoidal wing in the annular recess provided in the mouth
of the top container, this structure prevents, upon pressing
on the bottom container to effect the required dosage,
removal of the top container and/or of the tubular sleeve.
BRIEF DESCRIPTION OF THE DRAWINGS
The above and still further objects, features and
advantages of the present invention will become apparent
upon consideration of the following detailed description of
a specific embodiment thereof, especially when taken in
conjunction with the accompanying drawings wherein like
reference numerals in the various figures are utilized to
designate like components, and wherein:
Figure 1 shows a partially sectioned and exploded view
of the different elements that comprise a first embodiment
of the present invention;
Figure 2 is a partially sectioned view of the elements
of Figure 1 already assembled and once the seal has been
broken;
Figure 3 is an exploded view of each and every one of
the elements that comprises the invention, according to a
second embodiment;
Figure 4 shows a view equivalent to that of Figure 3,
with the exception that the elements are sectioned except
for the cap;
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Figure 5 shows a sectioned view of the second
embodiment, in which the elements are assembled and ready
for use, without the bottom of the top container having been
broken;
Figure 6 is a side view without sectioning of Figure 5;
Figure 7 is a sectioned view equivalent to that of
Figure 5, but with the exception that after having removed
the seal, the bottom of the top container has been broken
upon screwing down the cap and having subsequently removed
the cap;
Figure 8 is a side view without sectioning of Figure 7;
and
Figure 9 is a sectioned view of the top container.
DETAILED DESCRIPTION OF THE PRESENT INVENTION
Referring now to Figures 1 and 2, a bottom or lower
container 1 is illustrated. A product 4 to be mixed is
introduced into container 1. Bottom container 1 has a neck
2 in whose mouth an edge 3 has been provided.
A top or upper container S is disposed on the mouth of
container 1. Container 5 has a small flap, which includes
an annular rib 12 which causes top container 5 to be
retained on the edge 3 of the bot-tom container 1.
The top container 5 has a frangible bottom wall 6,
which is initially closed and sealed. Thus, a second
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product 7, which is eventually mixed with the one included
in the bottom container 1, is separated from product 4.
The top container 5 extends axially along a neck 8 in
which helicoidal threads 9 that permit screwing of a cap 18
are included.
The neck 8 is provided with a perimeter projection 10
that constitutes a ret~; n; ng means for the seal 19 of the
cap 18. The top part of tubular sleeve 13 terminates in a
discoidal wing 14 and a truncated-cone shaped portion 15
which can act as a medicine dropper.
The perimeter projection 10 has a plurality of sawteeth,
which are complemented by another plurality of sawteeth
provided in the interior surface of seal 19 of cap 18. In
this way, it is possible to screw cap 18 with its seal 19
until the seal contacts with the small flap of top container
5. In this manner, the locking of the seal 18 in the
perimeter projection 10 is produced by the actin of the
sawteeth. Upon unscrewing the cap 18 from the top
container, the seal 19 of the cap 18 breaks, ~k;ng it
possible to remove seal 19. In this manner, upon screwing
the cap 18 back onto the top container 5, cap 18 now comes
into contact with the perimeter projection 10. With the
movement of cap 18 downwardly, tubular sleeve 13 is pushed
axially causing the partial cutting of the bottom 6 by the
action of the bottom bevel edge 17. This breaking of seal 6
occurs easily and without any additional effort.
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Afterwards it is possible to mix the products 4 and 7,
which are administered in a dosed manner upon pressing on
the bottom container 1.
In this embodiment there are some problems regarding the
sealing and retaining of the elements with respect to the
other elements.
In order to solve these problems, a second embodiment is
- described below, where the perfect ret~;n;ng between the
different elements is established as well as a total sealing
between the elements. To obtain these objectives, in the
second embodiment, the top container 5 is provided with some
transversally placed sealing rings 21 which are complemented
with a sealing ring 25 provided close to the bottom edge of
the tubular sleeve 13 in the inside of the top container 5'.
Thus, total sealing between both containers is made
possible.
To facilitate the breaking of the bottom 6 of the top
container 5', the bottom of the tubular sleeve 13 has a
pointed decreasing cross section longitll~in~l projection or
appendix 24. Diametrically opposite from the appendix 24, a
longitudinal recess 27 is disposed. Recess 27 ensures that
the total cutting of the perimeter of bottom 6 of the top
container S' is prevented.
The discoidal wing 14 of the tubular sleeve 13, with its
peripheral edge, has a certain conicity defining a bevel 26.
Bevel 26 is complemented by an annular recess 22 provided in
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the mouth of the neck 8 of the top container 5'. Thus, upon
screwing down the cap, after removing the seal to break the
bottom 6 just as it has been described above in the first
embodiment, the bevel 26 remains axially retained in the
annular recess 22 in the mouth of the neck 8 of the top
container 5'. Accordingly, both elements are fastened
together in an effective manner.
A sealing ring is disposed in the top part of the neck
2 of the bottom container 1. Sealing ring 23 seals the
connection between the top container and the bottom
container, once the annular rib 12 is hooked in the edge 3
of the mouth of the bottom container 1.
The truncated-cone shaped portion 15 of tubular sleeve
13, operates as a medicine dropper with controlled dosage,
~hAnks to the use of inside coaxial cylinder 29. In the top
end thereof, the tubular sleeve 13 has a recess 28, that
mates with an inside projection of the cap 18', to guarantee
the sealing of the cap 18' with the tubular sleeve 13.
Therefore, the present invention provides three levels
of sealing and prevention mechanisms for improper use. The
first level is established between the bottom container 1
and the top container 5, the second between the tubular
sleeve 13 and the top container 5, and the third between the
cap 18 and the tubular sleeve 13.
The tearable or frangible bottom 6 of the top
container 5 is very thick in its center part, for the
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purpose of reducing migration through the bottom 6. An
inside perimeter weakening 30 and an outside perimeter
weakening 31 (See Fig. 9) are provided in bottom wall 6 to
prevent adequate tearing, and the production of particles in
the same. It should be noted that in the second embodiment,
an outside flap 20 is included. Flap 20 extend down
approximately half the length of the container 1 and
surrounds substantially all of the neck 2 of the bottom
container 1, after effecting the assembly of the different
elements.
Both embodiments permit the filling, with product 7,
of the bottom container 1, in the first place, sealing it
afterwards with the top container S or 5', that is filled
with product 4, closing the latter with the tubular sleeve
13 and finally screwing on the cap 18, 18'.
The present invention also permits other possible
solutions to effect the filling. In the first place of the
top container 5, 5', is filled with product 7, closing the
latter with the tubular sleeve 13, screwing on the cap 18,
18, and finally filling the bottom container 1, with the
product 4 and then sealing the entire device.
Another way to assemble the different elements
consists of filling the top container 5, 5', closing it with
the tubular sleeve 13, or filling the tubular sleeve 13
(with the cap 18, 18' being previously embossed) and the
subsequent sealing of the top container 5, 5'. This
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versatility of filling procedures permits the packaging of
fluids with different viscosities, solids, which may be
powder, lyophilized substances or pills.
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